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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00032215 | Registry Identifier | DRKS German Clinical Trials Register |
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| Name | Class |
|---|---|
| University Medicine Greifswald | OTHER |
| Wuerzburg University Hospital | OTHER |
| Goethe University | OTHER |
| University Hospital Schleswig-Holstein |
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Depressive disorders are among the most common psychiatric disorders. However, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. Within the framework of the P4D study, 1000 patients with depression will be comprehensively examined. In addition to the recording of psychological factors by means of questionnaires and third-party assessments, imaging and electrophysiological procedures (functional and structural MRI, EEG) are used to assess brain structure and function. In addition, blood is drawn from the subjects to analyze these samples for various biological markers (e.g., genetics). Drug level measurements are also performed.
The goal is to perform an in-depth characterization (phenotyping) of individuals with a depressive disorder. These findings could be used to individualize and improve therapy for depressive disorders.
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| Measure | Description | Time Frame |
|---|---|---|
| Remission after 7 weeks of treatment | The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off. | Baseline and Follow-up (Week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of psychometric changes in the clinical course of treatment | A range of psychometric information is collected. These include questionnaires, third party ratings and a cognitive assessment, as well as neuroimaging (functional and structural MRI), neurophysiology (EEG) and polysomnography (PSG). | Baseline and Follow-up (Week 7) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate to severe depressive disorder, aged between 18 and 70 years, who are undergoing inpatient treatment will be recruited. Patients should fulfil the inclusion criteria. All patients who meet the criteria are given information by a doctor and have the opportunity to ask further questions. Their participation in the study is voluntary and they give their written informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helge Frieling, Prof. Dr.med | Contact | +49 511 532-2427 | frieling.helge@mh-hannover.de | |
| Hannah B Maier, Dr. med. | Contact | +49 176 1532-8329 | maier.hannah@mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Helge Frieling, Prof. Dr.med | Hannover Medical School | Study Chair |
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Data sharing is planned.
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Data will be kept pseudonymised for 10 years and then anonymised.
Upon individual request, data may be made available before this time.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Blood samples are used for a variety of purposes. In addition to standard clinical laboratory tests, genetic (nanopore sequencing) and epigenetic (miRNA, methylation) tests will be performed. In addition, drug levels will be monitored regularly.
| Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment) |
Psychotherapy sessions (individual and group therapy) are recorded for 7 weeks. Alternative treatments (e.g. transcranial magnetic stimulation and electroconvulsive therapy) are also recorded. |
| Follow-up (Week 7) |
| Treatment/study dropout rates | Dropout rates are recorded with reasons. | Drop-out rates are collected throughout the data collection period, over two years. Starting at study enrollment of the first subject until complete completion of the last subject. |
| Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population | Representative population survey | The survey will be conducted over a 2-week period in late August / early September 2023. |
| Patient-doctor relationship | The Patient-Doctor-Relationship-Questionnaire (PDRQ-9) is used to assess the quality of the therapeutic relationship. | Baseline and Follow-up (Week 7) |